11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
FDA 510(k)
FDA Class 2
·Physical Medicine
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
DEPUY SIGMA PS FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 31, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·June 15, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 25, 2013
CHARGING SYS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 19, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·January 19, 2011
UNKNOWN DEPUY HUMERAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HSD·August 1, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 25, 2014
OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.
FDA Recall
Terminated
·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004